第七期：Biogen
Biogen Inc. (previously known as Biogen Idec) is an American multinational biotechnology company based in Cambridge, Massachusetts, specializing in the discovery, development, and delivery of therapies for the treatment of neurodegenerative, hematologic, and autoimmune diseases to patients worldwide.
History
Biogen was founded in 1978 in Geneva[2] by several prominent biologists, including Kenneth Murray of the University of Edinburgh, Phillip Allen Sharp of the Massachusetts Institute of Technology, Walter Gilbert of Harvard (who served as CEO during the start-up phase), Heinz Schaller, University of Heidelberg and Charles Weissmann, University of Zurich (who contributed the first product interferon alpha). Gilbert and Sharp were subsequently honored with Nobel Prizes: Gilbert was recognized in 1980 with the Nobel Prize in Chemistry for his work in understanding DNA sequencing, while Sharp received the Nobel Prize in Physiology or Medicine in 1993 for his discovery of split genes.
In 2003, Biogen merged with San Diego, California-based IDEC Pharmaceuticals (formed in 1986 by biotech pioneers Ivor Royston, Howard Birndorf and Robert E. Sobol) and adopted the name Biogen Idec. After the merger, Biogen Idec became the 3rd largest Biotechnology company in the world.[3] Following shifts in research core areas, the company has since shortened its name, reverting to simply Biogen.[4]Biogen stock is a component of several stock indices such as the S&P 100, S&P 500, S&P 1500, andNASDAQ-100 and the company is listed on the NASDAQ stock exchange under the ticker symbol, BIIB.[5]
In May 2006, the company announced it would acquire cancer specialist, Conforma Therapeutics for $250 million.[6] Later in the same month, the company announced its intention to acquire Fumapharm AG, consolidating ownership of Fumaderm and BG-12, an oral fumarate, which is being studied for the treatment of multiple sclerosis and psoriasis.[7]
In January 2007, the company announced it would acquire Syntonix Pharmaceuticals for up to $120 million, gaining Syntonix's lead product for hemophilia B as well as the technology for developing inhalable treatments.[8][9]
In February 2013, Bloomberg broke the news that Biogen was planning the pay Elan $3.25 billion for the full rights to Tysabri, used to treat multiple sclerosis.[10]
In January 2015 the company announced it will acquire Convergence Pharmaceuticals for up to $675 million, with the acquisition aiming to accelerate the development of Convergence's pipeline, in-particular CNV1014802 – a Phase II small molecule sodium channel blocking candidate.[11] In October 2015 the company announced it will lay off 11% of its workforce, effective immediately.[12]
Bioverativ
In May 2016 the company announced that it will spin off its hemophilia drug business (Eloctate and Alprolix) into a public company.[13] In August, the company announced that the spun off company would be called Bioverativ, in order to show heritage with Biogen.[14] The company will trade on the NASDAQ exchange under the ticker symbol BIVV[15][16] and will look to be spun off in early 2017.[17]
Acquisition history
The following is an illustration of the company's major mergers and acquisitions and historical predecessors (this is not a comprehensive list):
Products
Therapy | Indication (In United States unless otherwise noted) | Year Approved (US) | Year Approved (EU) | Additional Information |
ALPROLIX™ [CoagulationFactor IX (Recombinant), Fc Fusion Protein] | Control and prevention of bleeding episodes, perioperative management and routine prophylaxis in adults and children with hemophilia B | 2014 | 1993 | Also approved in Canada and Australia. Biogen and Swedish Orphan Biovitrum (Sobi) are collaborators in the development and commercialization of ALPROLIX. [18] |
Relapsing forms of multiple sclerosis | 1996 | 1997 | Includes the AVONEX PEN auto-injector and the AVOSTARTGRIP titration kit approved in the U.S. in 2012.[19] | |
ELOCTATE™ [Antihemophilic Factor (Recombinant), Fc Fusion Protein] | Control and prevention of bleeding episodes, perioperative (surgical) management and routine prophylaxis in adults and children with hemophilia A | 2014 | 1999 | Biogen and Swedish Orphan Biovitrum (Sobi) are collaborators in the development and commercialization of ELOCTATE.[20] |
FAMPYRA (prolonged-releasefampridine tablets) | Multiple sclerosis (Walking ability) | 2010 | 2011 | Marketed by Biogen in markets outside of the United States. Commercialized in the United States as AMPYRA (dalfampridine) Extended Release Tablets, by Acorda Therapeutics.[21] |
FUMADERM (fumaric acid esters) | Psoriasis German use | 1994 (Germany only) | Approved in Germany. Acquired in acquisition of Fumapharm AG in 2006.[22] | |
GAZYVA (obinutuzumab) | 2013 | 2014 | The first medicine approved with the FDA's Breakthrough Therapy Designation and is also currently in Phase 3 trials for NHL and diffuse large B-cell lymphoma. Currently commercialized in the United States by Genentech, a wholly owned subsidiary of Roche.[23] | |
SPINRAZA (nusinersen) | 2016 | 2017 | The first drug approved for the treatment of spinal muscular atrophy, developed in collaboration with Ionis Pharmaceuticals.[24][25] | |
PLEGRIDY (peginterferon beta-1a) | Relapsing forms of multiple sclerosis | 2014[26] | 2014[27] | |
RITUXAN (rituximab) | Non-Hodgkin's Lymphoma (NHL) Anti-TNF Refractory Rheumatoid Arthritis ANCA-Associated Vasculitis | 1997[28] 2006[29] 2011[30] | 1998 (as MabThera) | The first monoclonal antibody for cancer developed by IDEC, prior to merging with Biogen. Currently commercialized by Roche and its subsidiary, Genentech. |
TECFIDERA (dimethyl fumarate) | Relapsing forms of multiple sclerosis | 2013[31] | 2014[32] | |
TYSABRI (natalizumab) | Relapsing-remitting multiple sclerosis | 2004 Re-introduced in 2006 | 2006 | Full rights purchased from partner Elan in 2013.[33] |
Pipeline
Biogen has focused its R&D efforts on the discovery and development of treatments for patients with high unmet medical needs in the areas of neurology, hematology and immunology.
Investigational MS medicines:
· Daclizumab High-Yield Process (DAC HYP): is being developed as a potential once-monthly subcutaneous injection in the treatment of relapsing-remitting multiple sclerosis (RRMS). DAC HYP is being developed in collaboration with Abbvie, Inc. In June 2014, the companies announced positive top-line results from the Phase III DECIDE clinical trial, where DAC HYP demonstrated superiority over interferon beta-1a in annualized relapse rate.[34]
· Anti-LINGO-1 (BIIB033) (Opicinumab): is the first candidate being investigated for its potential to remyelinate and repair neurons damaged by MS, currently in Phase 2 trials.[35]
Biogen has several candidates in Phase 1 and 2 clinical trials in neurodegenerative and immunological diseases including MS, Alzheimer's disease, neuropathic pain, spinal muscular atrophy and lupus nephritis:
· Phase 2a: anti-LINGO-1 molecule (Opicinumab) in acute optic neuritis
· Phase 2b: anti-TWEAK monoclonal antibody in lupus nephritis
· Phase 2a: STX-100 in patients with idiopathic pulmonary fibrosis
· Phase 2: Neublastin for neuropathic pain in 2013
· Phase 3:[36] BIIB037 (Aducanumab), Biogen's first clinical study in Alzheimer's disease
· Phase 1/2: BIIB067 (ISIS-SOD1Rx) for amyotrophic lateral sclerosis, in collaboration with Ionis
Biogen also has several development agreements in place with Ionis Pharmaceuticals to collaborate to leverage antisense technology in advancing the treatment of neurological disorders.[37]
In February 2012, Biogen formalized a joint venture with Samsung, creating Samsung Bioepis. This joint venture brings Biogen's expertise and capabilities in protein engineering, cell line development, and recombinant biologics manufacturing to position the joint venture so Biogen can participate in the emerging market for biosimilars.[38]
In early 2014, Biogen entered into an agreement with Eisai, Inc., to jointly develop and commercialize two of their candidates for Alzheimer's disease, which have the potential to reduce Aβ plaques that form in the brains of patients, as well as to slow the formation of new plaques, potentially improving symptoms and suppressing disease progression.[39]
Biogen also has since 2015 an agreement with AGTC for the development of gene therapy for ophthalmologic diseases such as X-linked retinoschisis (XLRS) and X-linked Retinitis pigmentosa (XLRP), and up to three other genetic diseases. To this aim, Biogen paid AGTC $124 million, including an equity investment of $30 millions, and up to 1,1 billion in future milestones.[40]
References
1. a b c d e f "Biogen Inc. 2017 Annual Report (Form 10-K)". sec.gov. U.S. Securities and Exchange Commission. January 2018.
2. "Biotech's Comeback Kid". Forbes. Retrieved 2012-12-04.
3. "Idec to Merge With Biogen in $6.8 Billion Deal". New York Times. Retrieved 2003-06-24.
4. "Biogen Drops Idec From Name". Wall Street Journal. Retrieved 2015-03-23.
5. "Biogen Idec Inc. Stock Quote & Summary Data". NASDAQ.
6. PharmaTimes (2006-06-01). "Biogen Idec agrees to buy Swiss company Fumapharm". www.pharmatimes.com. Retrieved2017-12-28.
7. "Biogen Idec to Acquire Fumapharm AG; Consolidates Ownership of Oral Compound BG-12 Being Studied for Multiple Sclerosis". www.businesswire.com. Retrieved 2017-12-28.
8. "Biogen to buy Syntonix in $120M deal | FierceBiotech".www.fiercebiotech.com. Retrieved 2017-12-28.
9. "Biogen Idec to Acquire Syntonix".www.businesswire.com. Retrieved 2017-12-28.
10. "Biogen to Pay Elan $3.25 Billion for Full Tysabri Rights". Bloomberg.com. 2013-02-06. Retrieved 2017-12-28.
11. "Biogen Idec Snaps Up Convergence for Up-to-$675M - GEN News Highlights - GEN".
12. "Biogen is cutting 11% of its workforce".
13. D'Souza, Savio (May 3, 2016). "Biogen to spin off hemophilia drug business into a public company". Reuters. Retrieved May 3, 2016.
14. "Amid takeover chatter, Biogen introduces hemophilia spinoff Bioverativ - FiercePharma".
15. "Biogen Announces Bioverativ as Name of New Hemophilia-Focused Company | Business Wire". www.businesswire.com. Retrieved 2017-12-28.
16. "Biogen unveils name for hemophilia drug spinoff: Bioverativ - The Boston Globe".
17. "Biogen Announces Bioverativ as Name of New Hemophilia-Focused Company - Biogen Media".
18. "Does Biogen Idec Inc Have a New Blockbuster Hemophilia Therapy?". The Motley Fool. Retrieved 2014-07-04.
19. "Avonex". National MS Society.
20. "Biogen Idec's Eloctate gains FDA approval". The Pharma Letter. Retrieved 2014-09-06.
21. "Fampridine (Fampyra)". MS Trust.
22. "Biogen Idec enters deal to acquire Fumapharm". First Word Pharma. Retrieved 2006-05-31.
23. "FDA approves Gazyva for chronic lymphocytic leukemia". FDA.gov. Retrieved 2013-01-11.
24. Wadman, Meredith (23 December 2016). "Updated: FDA approves drug that rescues babies with fatal neurodegenerative disease". Science.
25. Grant, Charley (2016-12-27). "Surprise Drug Approval Is Holiday Gift for Biogen". Wall Street Journal.ISSN 0099-9660. Retrieved 2016-12-27.
26. "Biogen Idec's PLEGRIDY(Peginterferon Beta-1a) Approved in the US for the Treatment of Multiple Sclerosis". Reuters.
27. "Biogen Idec's Plegridy approved in Europe for relapsing-remitting multiple sclerosis". The Pharma Letter.
28. "FDA Approval for Rituximab". National Cancer Institute.
29. "UPDATE 1-Roche, Biogen end dispute over Rituxan follow-ons". Reuters. Retrieved 2010-10-21.
30. "FDA approves Rituxan to treat two rare disorders". FDA.gov. Retrieved 2011-04-19.
31. "Cell Therapeutics buys Zevalin from Biogen Idec for $10M, with up to $20M extra plus milestones". The Pharma Letter. Retrieved 2007-09-03.
32. "Tecifedra". National MS Society.
33. "Tysabri". National MS Society.
34. "Once-monthly MS drug from Biogen Idec, AbbVie clears Phase III hurdle". Fierce Biotech. Retrieved 2013-04-08.
35. "Lingo: a promising remyelination target in MS". Multiple Sclerosis Research. Retrieved 2014-06-16.
36. "Aducanumab Reduces Amyloid Plaques in Early Alzheimer's". PRIME.
37. "Isis Pharmaceuticals and Biogen Idec". Fierce Biotech.
38. "Biogen Sees Eloctate FDA Delay Pushing Marketing to Mid-2014". BusinessWeek. Retrieved 2013-12-11.
39. "Isis Pharmaceuticals and Biogen Idec". Fierce Biotech.
40. Biogen Offers Up To $1 Billion for AGTC’s Ophthalmology Gene Therapy, Xconomy Boston, David Holley, July 2nd, 2015,http://www.xconomy.com/boston/2015/07/02/biogen-offers-up-to-1-billion-for-agtcs-ophthalmology-gene-therapy/
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